Introduction

While drug-coated balloons (DCB) have demonstrated efficacy for coronary small vessel disease, comparative data between DCB and drug-eluting stents (DES) in de novo coronary lesions remain limited.

Aim

This study hypothesized that a DCB-only strategy would be non-inferior to DES for angiographic outcomes in de novo small vessel coronary lesions.

Material and methods

This prospective randomized controlled trial (RCT) enrolled 228 patients with de novo (≥ 70% stenosis), non-complex coronary lesions from January 2022 to January 2024. Participants were randomized 1 : 1 to paclitaxel-coated balloon or rapamycin-eluting stent (DES). The primary endpoint was late lumen loss (LLL) at 6 and 12 months post-procedure, with a non-inferiority margin of 0.15 mm. Baseline clinical characteristics were compared between groups, with 12-month follow-up assessments including cardiac function, major adverse cardiovascular events (MACE), post-procedural angina, and bleeding events. Quantitative coronary angiography was used to evaluate minimal lumen diameter, percent stenosis, and LLL. Kaplan-Meier analysis was used to assess cumulative survival rates.

Results

Baseline clinical characteristics were similar between groups (p > 0.05). The DCB group had more Mehran Type I lesions (p < 0.05). Both groups reduced thrombogenic potential (p < 0.05). There were no significant differences in angiographic outcomes, MACE, or BARC ≥ 3 bleeding (p > 0.05). At 6 and 12 months, the 95% CI upper limits for LLL difference were below 0.15 mm (p for non-inferiority < 0.001). DCB had lower post-procedural angina frequency (p < 0.05) but similar episode duration. Survival rates did not differ significantly (p > 0.05).

Conclusions

For de novo, non-complex small coronary vessel disease, DCB monotherapy demonstrates comparable long-term efficacy to DES, meeting non-inferiority criteria.